Comparison of treatment outcomes of balloon dilation of stenoses of the leg arteries with drug-coated and uncoated balloon catheters
Zusammenfassung der Studie
This study investigates patients with a vascular stenosis of the leg arteries that affects blood supply. We conduct this study to compare whether the dilation of the vascular stenosis using a drug-coated balloon catheter is similarly effective or better than with an uncoated balloon catheter. We aim to compare the efficacy, safety, and tolerability of common balloon catheters. Uncoated balloons have been used for decades to treat vascular stenoses. Coated balloons contain a drug on the balloon surface, which is pressed into the vessel wall during the dilation of the balloon in the narrowed vessel. The drug remains in the vessel wall for several weeks and is intended to prevent the re-narrowing of the vessel due to excessive scar formation by inhibiting cell growth. The drug used here is Sirolimus, which aims to prevent cell overgrowth and thus the re-narrowing of the affected vessel. Sirolimus-coated vascular stents have been used for many years in obstructed coronary arteries with good results. Coated balloons have also been used for many years in obstructed leg arteries, but it has never been attempted to demonstrate whether this treatment has a benefit on relevant outcomes, including limb preservation (prevention of amputations) and repeated emergency interventions on the leg.
(BASEC)
Untersuchte Intervention
It is examined whether the dilation of the vascular stenosis using a drug-coated balloon catheter is similarly effective or better than with an uncoated balloon catheter.
(BASEC)
Untersuchte Krankheit(en)
This study investigates peripheral arterial occlusive disease. Affected patients suffer from a stenosis or occlusion of one or more leg arteries, which affects blood supply. This is treated endovascularly (i.e., from within through a small access, usually via the groin).
(BASEC)
- adult patients - patients for whom balloon dilation of an obstructed leg artery is planned - patients who give their consent to the study (BASEC)
Ausschlusskriterien
- pregnant and breastfeeding women, or women who have planned a pregnancy - patients with a known intolerance to Sirolimus - patients participating in another clinical study (BASEC)
Studienstandort
Freiburg, Zürich
(BASEC)
Sponsor
Universitätsspital Zürich, Klinik für Angiologie
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Rebecca Spescha
+41 43 253 03 71
rebecca.spescha@clutterusz.chUniversitätsspital Zürich Klinik für Angiologie Rämistrasse 100 8091 Zürich
(BASEC)
Allgemeine Auskünfte
University of Zurich
(ICTRP)
Wissenschaftliche Auskünfte
University of Zurich,
+41432530371
rebecca.spescha@clutterusz.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
05.03.2020
(BASEC)
ICTRP Studien-ID
NCT04238546 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Major adverse limb events in patients with femoro-popliteal and below-the-knee peripheral arterial disease treated with either sirolimus-coated balloon or standard uncoated balloon angioplasty. The 'SirPAD' randomized controlled trial (BASEC)
Wissenschaftlicher Titel
Major Adverse Limb Events in Patients With Femoro-popliteal and Below-the-knee Peripheral Arterial Disease Treated With Either Sirolimus-coated Balloon or Standard Uncoated Balloon Angioplasty (ICTRP)
Öffentlicher Titel
Major Adverse Limb Events in Patients With Femoro-popliteal and Below-the-knee Peripheral Arterial Disease Treated With Either Sirolimus-coated Balloon or Standard Uncoated Balloon Angioplasty (ICTRP)
Untersuchte Krankheit(en)
Peripheral Arterial Disease (ICTRP)
Untersuchte Intervention
Device: sirolimus-coated balloon catheterDevice: uncoated balloon catheter (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
Inclusion Criteria:
- Age > 18 years
- Patients requiring endovascular angioplasty for PAD located below the inguinal
ligament
- Written informed consent obtained from participant or legal guardian prior to
randomization in patients requiring emergency interventional treatment who are
temporarily not capable of providing informed consent, consent will be subsequently
obtained after the procedure if strict conditions apply. These include the
assessment of the presumed will and patient decree, and requires the allocation of
an independent physician
Exclusion Criteria:
- Pregnancy, breastfeeding, or planned pregnancy within the trial period or women of
childbearing potential not using an adequate method of contraception
- Patients with known intolerance or allergy to sirolimus
- Participation in this or other clinical trials during the previous 3 months (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
unplanned major amputation of the target limb;endovascular or surgical target lesion re-vascularization for critical limb ischemia (ICTRP)
composite of unplanned (major or minor) index-limb amputations or any target lesion re-vascularization within 365 days after enrolment (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Nils Kucher, Prof.;Rebecca Spescha, Dr. sc. nat, rebecca.spescha@usz.ch, +41432530371, University of Zurich, (ICTRP)
Sekundäre IDs
SirPAD Trial (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT04238546 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar